Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
escitalopram oxalate, Quantity: 25.551 mg/mL (Equivalent: escitalopram, Qty 20 mg/mL)
Lundbeck Australia Pty Ltd
escitalopram oxalate
Oral Liquid, solution
Excipient Ingredients: sodium hydroxide; ethanol; purified water; propyl gallate; citric acid
Oral
15 mL
(S4) Prescription Only Medicine
Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder.
Visual Identification: Clear, nearly colourless to yellowish solution; Container Type: Bottle; Container Material: Glass Type II Coloured; Container Life Time: 8 Weeks; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert
Registered
2014-03-27
LEXAPRO ® ORAL SOLUTION L E X A P R O ® V e r s i o n 2 . 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING LEXAPRO? LEXAPRO contains the active ingredient escitalopram. LEXAPRO is used to treat depression. For more information, see Section 1. Why am I using LEXAPRO? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LEXAPRO? Do not use if you have ever had an allergic reaction to Escitalopram or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use LEXAPRO? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with LEXAPRO and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE LEXAPRO? • Your doctor will decide what dose you will receive. • The standard dose for this medicine is 10 mg per day. This may be increased by your doctor to 20 mg per day. More instructions can be found in Section 4. How do I use LEXAPRO? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LEXAPRO? THINGS YOU SHOULD DO • REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING LEXAPRO. • IF YOU BECOME PREGNANT WHILE TAKING LEXAPRO, TELL YOUR DOCTOR IMMEDIATELY. • TELL YOUR DOCTOR IMMEDIATELY IF YOU HAVE THOUGHTS ABOUT KILLING YOURSELF. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly, or lower the dosage without telling your doctor. • Do not give the oral solution to anyone else, even if they have the same condition as you. • Do not let yourself run out of medicine over the weekend or on holidays. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how LEXAPRO affects read_full_document
LEXAPRO® (escitalopram oxalate) _ _ _Page 1 of 35 _ AUSTRALIAN PRODUCT INFORMATION – LEXAPRO (ESCITALOPRAM OXALATE) FILM-COATED TABLETS AND ORAL SOLUTION 1 NAME OF THE MEDICINE Escitalopram oxalate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LEXAPRO tablets 10mg and 20mg: Film-coated tablets containing 10mg and 20 mg escitalopram (as oxalate) LEXAPRO solution 20 mg/mL:_ _Oral solution containing 20 mg/mL escitalopram (as oxalate) Excipient with known effect: ethanol. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM LEXAPRO 10 mg tablets are oval, white, scored, film-coated tablets marked with "E” and “L" on one side. LEXAPRO 20 mg tablets are oval, white, scored, film-coated tablets marked with "E” and “N" on one side. LEXAPRO 20 mg/mL oral solution is a clear, nearly colourless to yellowish solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS Escitalopram is administered as a single oral dose and may be taken with or without food. The oral solution can be mixed with water, orange juice or apple juice. LEXAPRO® (escitalopram oxalate) _ _ _Page 2 of 35 _ Turn the bottle completely upside down. If no drops come out, tap the bottle lightly to start the flow. _Major depression _ Usually 2 - 4 weeks are necessary for antidepressant response,_ _ The recommended dose is 10 mg (one 10 mg tablet or 10 drops of the 20 mg/mL oral solution) once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg (one 20 mg tablet or 20 drops of the 20 mg/mL oral solution) daily, although the onset of therapeutic effect may be seen earlier. The treatment of a single episode of depression requires treatment over the acute and the medium term. After the symptoms resolve during acute treatment, a period of consolidation of the read_full_document